Vietnam influenza A / H1N1 vaccine may be released after 6 months
Vaccine and Biologicals Company No. 1 is completing procedures to receive the gene of influenza A / H1N1 virus that has been attenuated from the World Health Organization (WHO) to carry out the production of vaccines against AH1N1 at Vietnam.
Dr. Nguyen Thu Van, Director of Vaccine and Biology Company No. 1 (Vabiotech) said that 7 - 10 days from now, WHO's products will return to Vietnam. When the original virus strain is available, Vietnam can fully produce the vaccine against influenza A / H1N1 within 6 to 12 months.
Inheriting technology available from influenza A / H5N1 vaccine
At Vabiotech, since 2007, the project has developed a technological process for the production of H5N1 vaccine in Vietnam, implemented by Vabiotech scientists, which has been accepted by the Ministry of Health. Dr. Nguyen Thu Van said that the first H5N1 vaccine products have been produced in the laboratory and are being tested on volunteers.
Testing vaccines in the laboratory at the Center for research and production of vaccines and medical bio-products (Ministry of Health).Photo: VNA.
However, the study and production of A / H5N1 influenza vaccine was conducted on monkey kidney cells. Meanwhile, flu vaccines being used around the world are produced on embryonic chicken eggs.
More convenient than Vabiotech, the Institute of Vaccines and Medical Biologicals has previously mastered the technology of producing many vaccines for the nation's expanded immunization program. Dr. Le Van Hiep, Director of the Institute of Vaccines and Medical Biologicals, said that since 2005, this unit has also collaborated with the Institute of Biotechnology (Vietnam Academy of Science and Technology) to begin research, Production of vaccines against influenza A / H5N1. In particular, the vaccine against influenza A / H5N1 by this unit is also produced on chicken eggs with embryos. According to WHO's announcement, this environment is perfectly suited to the culture of the A / H1N1 flu vaccine provided by WHO.
In addition to Vabiotech, the Institute of Vaccines and Medical Biologicals, the Ho Chi Minh City Pasteur Institute also has the ability to research and produce A / H1N1 influenza vaccines.
According to Dr. Nguyen Thu Van, the study of successful production of influenza A / H5N1 vaccine is the basis for conducting the production of vaccines against influenza because the vaccine production processes are nearly the same.
Just wait for samples
The good news is that since the beginning of June 2009, the Institute of Vaccines and Medical Biologicals has been assigned by the Ministry of Science and Technology to carry out a project to test the vaccine against influenza A / H1N1. Accordingly, each year this unit will produce about 50,000 doses for clinical testing.
Dr. Le Van Hiep said that in the next 10 days, the weak A / H1N1 influenza virus strain (attenuated virulence) provided by WHO will return to Vietnam. Thus, after about 6 months, domestic production units can completely produce the first batch of H1N1 vaccine.
Research on vaccine production for AH5N1 influenza at Vaccine and Biology Company No. 1. Photo: Khanh Linh
Dr. Nguyen Thu Van said that Vabiotech just waited for WHO's product. If this sample can be suitable for culture on monkey kidney cells, the production of vaccine for influenza A / H1N1 will be shortened because there is no need to study and test the culture environment.
However, in order for the vaccine lot to be marketed, it has to undergo a lot of thorough evaluation. Dr. Dinh Duy Khang, head of the Department of Molecular Microbiology (Biotechnology Institute), in collaboration with the Institute of Vaccines and Medical Biologicals, researches and produces vaccines for influenza A H5N1, said. Usually, after production, the product must be inspected at the production facility on the criteria: safety, immunity, and sterility.
After that, the Scientific and Technical Council tested and accepted the technical features, processes, standards, production conditions (GMP) and brought samples to the National Institute for testing of vaccines - medical and biological products. determined. After meeting the requirements, the Medical Ethics Council (Ministry of Health) is required to assess the possibility of clinical testing on humans. This process lasts at least 6 months or more.
The fact that China recently announced its success in producing vaccines against H1N1 flu is due to different ways of doing so. According to Dr. Le Van Hiep, Director of the Institute of Vaccines and Medical Biologicals, China does not wait for the international strains provided from WHO to produce vaccines but self-study and isolate the original strains. from patients, from epidemics . to produce vaccines. However, the absence of the original strain also makes it difficult for the Chinese vaccine to be commercialized by the WHO because it has to re-prove the study of the original strain.
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